BEUDAMED
    FDA Enforcement Class II Ongoing

    Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS. Sterile surgical drape.

    Recall: Z-1364-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1364-2025
    Event ID
    96401
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2025
    Initiation Date
    February 13, 2025
    Classification Date
    March 14, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS. Sterile surgical drape.

    Reason

    Potential breach in pouch packaging which could lead to loss of sterility.

    Code Info

    Item No. DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A; UDI (case): 40080196308126, 40080196308133, 40080196722892, 40080196308195, 40080196722946, 40080196753391, 40884389110295, 40080196915416; UDI (each): 10080196308125, 10080196308132, 10080196722891, 10080196308194, 10080196722945, 10080196753390, 10884389110294, 10080196915415; Lot No. 31124090044H, 31124090028F, 31124080024F, 31124080061F, 31124090029F, 31124090089F, 31124100077F, 31124090030H, 31124090054F, 31124070070F, 31124080063F, 45024090166, 31124100007F.

    Distribution

    US Nationwide distribution.

    Quantity

    1,490 units